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Not Yet Recruiting NCT05658887

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Conditions: Pelvic Organ Prolapse, Perioperative/Postoperative Complications

Sex: Female
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 110
Sponsor: Joseph Kowalski

Location: United States

Summary

This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.

Eligibility Criteria

Inclusion Criteria:Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension)FemaleAge 18 or higherExclusion Criteria:Non-English speakingIncarceratedCognitive impairment precluding informed consentChronic opioid userChronic gabapentinoid userContraindication to acetaminophen, celecoxib, or gabapentinoidsConcurrent laparoscopic or abdominal surgery

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05658887). StuddyBuddy aggregates publicly available trial information.